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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00897676
Other study ID # 2008-10-6255
Secondary ID R01FD004905
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date May 2009
Est. completion date January 2017

Study information

Verified date March 2020
Source Children's Hospital of Philadelphia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism. Funding Source - FDA Office of Orphan Products Development (OODP).


Description:

This is a placebo controlled study with randomized crossover design to evaluate the effect of the glucagon-like peptide-1 (GLP-1) receptor antagonist, exendin-(9-39), on fasting blood glucose levels, protein-induced hypoglycemia, and fasting tolerance of subjects with congenital hyperinsulinism due to mutations in the ATP- sensitive potassium channel (KATP) channel.


Recruitment information / eligibility

Status Completed
Enrollment 17
Est. completion date January 2017
Est. primary completion date August 26, 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months to 18 Years
Eligibility Inclusion Criteria:

- Confirmed diagnosis of hyperinsulinism

- Mutation analysis results demonstrating KATP channel defect

- Age 6 months to 18 years with

- Persistent hypoglycemia

Exclusion Criteria:

- Current therapy with medications that may affect glucose metabolism such as octreotide, diazoxide, high dose glucocorticoids, adrenergic agents, etc. Subjects will be eligible to participate if the last dose of octreotide is given 48 hrs before study day 1 and the last dose of diazoxide is given 72 hours before study day 1

- Evidence of a medical condition that might alter results or compromised the elimination of the peptide, including active infection, kidney failure, severe liver dysfunction, severe respiratory or cardiac failure

- Pregnancy

- Subjects with milk protein allergy will be excluded for participating in studies involving protein tolerance test

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Exendin-(9-39)
100-500pmol/kg/min
placebo
placebo (0.9% NaCl)

Locations

Country Name City State
United States The Children's Hospital of Philadelphia Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Diva De Leon

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Area Under the Curve (AUC) Plasma Glucose Area under the curve plasma glucose from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion Time 0 min - time 360 min
Secondary Area Under the Curve (AUC) Plasma Insulin Area under the curve plasma insulin from the initiation of infusion of vehicle or exendin-(9-39) to end of the infusion time 0 min to time 360 min
Secondary Area Under the Curve (AUC) Plasma C-peptide Area under the curve plasma C-peptide from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion time 0 min to time 360 min
Secondary Area Under the Curve (AUC) Plasma Glucagon Area under the curve plasma glucagon from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion time 0 min to time 360 min
Secondary Area Under the Curve ( AUC) Plasma Total GLP-1 (Glucagon-like Peptide-1) Area under the curve plasma total GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion time 0 to time 360 min
Secondary Area Under the Curve ( AUC) Plasma Active GLP-1 (Glucagon-like Peptide-1) Area under the curve plasma active GLP-1 (glucagon-like peptide-1) from the beginning of the infusion of vehicle or exendin-(9-39) to the end of the infusion time 0 min to time 360 min
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